Z-1828-2024Class II

Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

Name: Z-1828-2024 Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Creator: Andover Healthcare Inc.
Published: 2024-04-02
License: https://open.fda.gov/license/

Andover Healthcare Inc. / initiated 2024-04-02 / Open, Classified / root cause: manufacturing process

FDA source

Andover Healthcare Inc. began a recall of Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) on 2024-04-02. FDA classified it as Class II and gives the reason as "A packaging seal gap could impact the sterility of the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1828-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-02
Posted: 2024-05-15
Recalling firm: Andover Healthcare Inc.
Product: Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Product code: FQM Bandage, Elastic
Reason for recall: A packaging seal gap could impact the sterility of the product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 2, 2024, customers were notified via phone, email and certified mail. Actions to be taken by customer/user: Please identify and return all cases of Batch 0031151359, Lot 10009897233 Sterile CoFlex NL, Tan, 4INx5YD (5400S) made January 2024, shipped February 2024 - March 2024. Please make sure everyone in your organization is fully aware of this corrective action and follows these instructions. 1. Please discontinue the distribution and use of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL Tan 4INx5YD (5400S). 2. Please identify all customers that purchased inventory of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL Tan 4INx5YD (5400S). Email the attached Customer Notice to each of those customers so that they can participate in the recall. If you have a physical address, please also mail them the attached Customer Notice. Retain written proof that the Customer Notice has been sent and received. We will reimburse you for your postage and shipping costs upon receipt of reasonable proof of those costs. If you would prefer for us to handle the communications to your customers, we will do so at no charge if you provide all available contact information. Refer to our contact information below for all questions and requests for reimbursement. 3. Please return all cases of Batch 0031151359, Lot 10009897233, Sterile CoFlex NL, Tan, 4INx5YD (5400S) to OVIK Health, LLC, c/o Customer Care, 9 Fanaras Drive, Salisbury, MA 01952. 4. Please phone or email your acknowledgement of this recall notice (using the attached Acknowledgement and Receipt Form or otherwise) to: Phone: 1 (800) 432-6686 (toll free), E-mail: [email protected]. Upon receipt of returned products, OVIK Health, LLC will issue a credit. We will continue to provide these products with minimal interruption in the supply chain. For further information, questions, or concerns please do not hesitate to reach out to OVIK Health, LLC at: Monday through Friday, 8:00 AM to 4:30 PM, Eas
Quantity in commerce: 108 cases (1,944 individual product packages)
Distribution: US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Product codes and lots: Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)